Cleared Special

K151460 - Fully Automatic Electronic Blood Pressu...

K151460 is the FDA 510(k) clearance for Fully Automatic Electronic Blood Pressu... by Andon Health Co, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 99-day FDA review.

K151460 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
99d
Days
Class 2
Risk

K151460 is an FDA 510(k) clearance for the Fully Automatic Electronic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on September 8, 2015 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K151460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date September 08, 2015
Days to Decision 99 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00723814 Completed Observational Industry-sponsored

Blood Pressure Monitor Clinical Test

Condition studied Blood Pressure
Sponsor Andon Health Co., Ltd (industry)
Primary outcome
monitor the diastolic and systolic
Study completed - no results published. This trial concluded in but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 355
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K151460.
iHealth Track Blood Pressure Monitor
K160014 · Andon Health Co, Ltd. · Feb 2016
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · Andon Health Co, Ltd. · Sep 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · Andon Health Co, Ltd. · Sep 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K141984 · Andon Health Co, Ltd. · Apr 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K140121 · Andon Health Co, Ltd. · Jul 2014
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
K140312 · Edwards Lifesciences, LLC · Jun 2014